Field of the Invention
This invention relates to a pharmaceutical composition containing herbal ingredients for the treatment of diabetes mellitus and more particularly, to the antidiabetic composition comprising 1) 15 herbal ingredients (i.e., Shinseng Radix, Coptis Rhizoma, Ligustri Fructus Semen, Salix spp. Cortex, Rhei coreani Rhizoma, Anemarrhena Rhizoma, Salviae Radix, Scrophulariae Radix, Lycii Cortex Radicis, Reynoutriae Radix, Platycodi Radix, Astragali Radix, Puerariae Radix, Atractylis Rhizoma, and Morus alba Radix Cortex), 2) vitamins such as Bi and B6, and 3) zinc, manganese, chromium, germanium as inorganic materials.
The antidiabetic herbal composition of this invention for the prevention and treatment of diabetes serves to lower the glucose level in diabetic patients and prevent the destruction of beta-cell in the pancreas, while increasing insulin secretion based on the mechanism of recovering the function of damaged beta-cell. Further, the antidiabetic herbal composition of this invention is quite effective in the treatment of insulin-dependent (type I) diabetes and non-insulin-dependent (type II) diabetes, since it shows the constant therapeutic effect due to better stability of therapeutic effect among individual patients.
Diabetes with its complications is a disease showing a high mortality worldwide in line with other diseases such as cancer, cardiovascular disorders. The mortality of diabetes has persisted and there are many reports that the diabetic patients have a high risk of having some related complications in eye, kidney and heart.
The symptoms of diabetes may vary but its main three complaints are excessive water intake, excessive urination and excessive food intake. More specifically, the glucose level in the blood becomes abnormally high, causing excessive urination and constant thirst and hunger. The body""s inability to store glucose causes weight loss.
There are two main types of diabetes mellitus such as insulin-dependent (type I) diabetes and non-insulin-dependent diabetes (type II). Insulin-dependent diabetes tends to cause severe symptoms such as diabetic ketoacidosis due to the severe insufficiency of insulin. In Europe and U.S.A., insulin-dependent diabetes accounts for about 5xcx9c10% in all diabetic patients, while it represents about 1xcx9c2% in Korea. Insulin-dependent diabetes is called xe2x80x9cyouth diabetesxe2x80x9d, since it appears in teenagers and youngsters in their twenties. The cause of insulin-dependent diabetes is associated with some gene factor such as HLA antigen (HLA, DR, DQ). Another environmental factors inducing insulin-dependent diabetes include viruses and some toxic materials that may affect the immune source as the surface antigen of beta-cell, insulin-secreting cell in the pancreas. The autoimmune mechanism has shown to be involved in the occurrence of diabetes, thus producing the auto-antibody against Langerhans island cell and insulin. Recently, efforts have been made to slow or prevent the occurrence of insulin-dependant diabetes by detecting the auto-antibody in an earlier stage.
The other main type, non-insulin-dependent diabetes, is usually of gradual onset and occurs in people over 40 years old. Unlike insulin-dependent diabetes, type II diabetes is called xe2x80x9cadult diabetesxe2x80x9d and its etiology has been unknown. Evidences have shown that non-insulin-dependent diabetes may be associated with genetic and environmental factors. In the case of non-insulin-dependent diabetes, it tends to heavily run in families and identical twins who has the genes responsible for the non-insulin-dependent diabetes by 90xcx9c100%. When both parents have diabetes, 58% of children may have diabetes; when one of the parents has diabetes, 27% of diabetes may occur in children; when both parents are normal, only 0.9% of diabetes may occur in children. The environmental factors responsible for diabetes include high-calorie food intake triggered by rapid economic growth in recent years, insufficient exercise, obesity, stress and drug overuse. The pathology of non-insulin-dependent diabetes may be associated with insufficient secretion of insulin and malfunction of insulin at target cell (insulin resistance) but the primary factor has yet to be elucidated.
The examples of oral glucose-lowering agents for the treatment of diabetes include sulfonylureas, biguanides and acarbose. The second-generation sulfonylureas have been frequently used, since its duration of action is short with a potent glucose-lowering effect in non-obese diabetic patients, while biguanides and acarbose are indicated for obese diabetic patients exceeding the normal body weight.
The marked difference among these anti-diabetic agents is that biguanides and acarbose has less incidence of hypoglycemia than sulfonylureas.
Special attention, especially in the elderly people, should be exercised when an injecTable form of insulin is administered, since hypoglycemia may occur and its use is quite inconvenient.
In addition to these drug medications, there are 158 traditional drugs including 153 oral drugs in Korea. It has been reported that about 73% of adult diabetic patients have experienced the traditional antidiabetics more than once.
The current research for antidiabetics has focused on the prevention and treatment of diabetes. In the case of insulin-dependent diabetes, some animal experiments using NOD mice model have been mainly performed for the prevention of insulitis and diabetes. The majority of antidiabetic approaches have been centered on the inhibition and modulation of immune response for preventing the destruction of beta-cell. Insulin-dependent diabetes, an autoimmune disease, is caused by abnormal potentiation of immune function. Diverse immunotherapies designed to prevent the destruction of beta-cell in the pancreas have been applied. Neonatal thymectomy can eliminate T-cell in NOD mice, which may contribute to the inhibition of diabetes. Evidences have shown that the elimination of T-cell and macrophage via appropriate modulation of antibody against T-cell may also prevent the occurrence of diabetes. Another studies have indicated that the use of various antioxidants that inhibits the formation and action of free radicals such as NO secreted from the immune cell may inhibit the occurrence of diabetes. These oxidants include nicotinamide, vitamin E, probucol, MDL29311 and U78518F.
Many studies have been actively conducted based on immunosuppressants but glucocorticoid and cyclophosphamide have failed to demonstrate their significant efficacy against diabetes. Another strategies using cyclosporin A, rapamycin and FK506 have been suggested, but its results are unclear. The use of immunosuppressants as antidiabetic drug has faced some problems associated with side effects such as secondary infection, renal and hepatic toxicities due to the excessive immune suppression, and their long-term use may induce cancer. The recent studies have shown that some immunomodulators, not immunosuppressants, for the prevention and treatment of diabetes may inhibit diabetes in NOD mice via modulation of cytokines such as IL-4 and -IL-10. Evidences have indicated that some immunomodulators such as OK-432, LZ-8, BCG, and CFA may contribute to the treatment of diabetes, but their mode of action have yet to be elucidated.
Currently, investigators have endeavored to develop a novel drug with less side effects for the treatment of both insulin-dependent and non-insulin dependent diabetes. It has been reported that oriental medicines have diverse therapeutic efficacy with less side effects in a traditional term. Some studies have demonstrated that oriental medicine-based regimens using many herbs singly or in combination have proven their superior efficacy in the treatment of diabetes, even in the treatment of both insulin-dependent and non-insulin dependent diabetes simultaneously.
In this context, the inventor has undertaken the intensive studies to develop a pharmaceutical composition for the treatment of both insulin-dependant and non-insulin-dependant diabetes simultaneously based on the mixture of various herbal ingredients with less side effects. For the treatment of insulin-dependant diabetes, a drug designed to prevent the destruction of beta-cell in the pancreas and to facilitate the secretion of insulin in beta-cell is essential. Thus, the challenging task was achieved in animal experiments using STZ and NOD mice. Further, the effective treatment of non-insulin-dependant diabetes could be achieved by the inhibition of the drastic increase of glucose level after food intake and alleviation of insulin resistance in the peripheral tissues; in this case, KK-Ay mice were used and the inventor found that the herbal composition of this invention has a glucose-lowering effect with stability of the therapeutic effect among individuals, thus, this invention has been completed. Therefore, the object of this invention is to provide a novel herbal composition for the treatment of both insulin-dependant and non-insulin-dependant diabetes. This invention is explained in detail as set forth hereunder.